Operations QA Associate

Operations San Francisco, California


Description

Spire Health is currently seeking an experienced Operations QA Associate.  This role will be the go-to person for any quality related tasks in the kitting and fulfillment areas.  They are responsible for performing incoming, first article inspection, in-process and final quality inspections and related activities. In addition, they will assist and support fulfillment (by performing kitting or other assembly steps) when demand surges. 

Responsibilities:

This role is responsible for reviewing device history records (LHRs) for accuracy and completeness, certifying compliance to product specification and traceability requirements and ensuring that any deviations from the manufacturing process were properly recorded and authorized by members of the appropriate departments.

The QA Associate receives guidance on workload prioritization from the team lead, but is ultimately responsible for organizing and executing their projects and daily workload in a manner which meets the schedules of the operational teams whom they support to get product out the door.  They will be cross trained on fulfillment procedures to support and flex up capacity to support surges as we grow. 

  • Prepare and maintain Quality records for review of completeness and accuracy to meet both internal and external expectations.
  • Assist with the identification and development of required procedures and processes related to the Quality Management System.
  • Initiate and process Non-Conforming Material Reports when required and document nonconforming material; clearly and accurately.
  • Review equipment calibration, validation, and maintenance records to ensure they are performed correctly and on time.
  • Communicate to all individuals effectively.
  • Participate in process improvement teams and/or complete relative documentation when required and team meetings as required (safety, problem solving, etc.).
  • Assist in inspections of purchased parts, subassemblies or finished company products according to specifications or standards using standard physical, mechanical and/ or electrical measurements as required.
  • Accurately document the results of the inspections and testing on data sheets/forms as applicable.
  • May perform in-process and/or final quality inspections and assists with manufacturing record review.
  • Evaluate problems and make initial recommendations for possible corrective action to supervise.
  • Compiles monthly quality data for inspection as necessary.
  • Perform other duties as assigned by the Quality Management team and Fulfillment Operations as needed.

Qualifications:

  • Associates Degree
  • 3 years’ experience in precision inspection and quality systems, in a medical device manufacturing environment or other regulated environment
  • Ability to work independently, prioritize activities and communicate well
  • Ability to read and comprehend engineering drawings and schematics (Blueprint, 2D and 3D model reading knowledge)
  • Ability to work well within and across departments to provide excellent customer service
  • Good problem-solving skills. Attention to detail, accurate and concise.
  • Able to keep neat and organized records and files
  • Strong computer skills and familiar with Microsoft Windows applications; and written and oral communication skills, and able to read and write in English
  • Be able to perform basic physical tasks such as lifting 50lbs, reading, nimbleness of hands for typing and writing
  • Emphasizes personal and professional growth, keeps knowledge and skills current

Spire Health also provides additional benefits and is an Equal Opportunity Employer (M/F/V/D).